NavaClick Syringe and Needle Model LIN02 Recalled for Incorrect Carton GTIN Label
Lineage Biomedical is recalling NavaClick Syringe and Needle Model LIN02 due to an incorrect GTIN number on carton packaging. The recall affects 215 cartons distributed in Michigan and South Carolina.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving only a labeling issue. The incorrect GTIN on the carton is an identification problem with no reported safety hazard, product defect, or patient risk. Class III recalls are typically severity 1 or 2, and this pure documentation error warrants a severity of 1.
Plain-English summary
Lineage Biomedical, Inc. is recalling NavaClick Syringe and Needle, Model Number LIN02, distributed in the United States. The recall involves 215 cartons, each containing 50 pouches, with distribution in Michigan and South Carolina.
The cartons have been printed with an incorrect GTIN (Global Trade Item Number) on the packaging label. The GTIN is the barcode identifier used for product tracking and inventory management in healthcare settings.
This is a documentation issue that does not affect the safety or functionality of the syringes and needles themselves. Affected facilities should verify their inventory against the product UDI codes provided by the FDA and contact Lineage Biomedical for guidance on product disposition or replacement.
The recalled product
- Product
- NavaClick Syringe and Needle, Model Number LIN02
- Manufacturer
- LINEAGE BIOMEDICAL, INC
- Hazard
- labeling-error
Distribution
Distributed nationwide across the United States.
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